Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00226499 | Evaluate Vaccine Against Chickenpox and a Combined Vaccine Against 4 Viral Childhood Diseases: Measles, Mumps, Rubella and Chickenpox | PHASE3 | COMPLETED | 5,803 | — | — | Sep 1, 2005 | Oct 12, 2006 | Sep 23, 2019 | 104 | Czechia, Greece +8 |
| NCT00578175 | Immunogenicity and Safety of GlaxoSmithKline Biologicals' MMRV Vaccine vs. ProQuad® in Children 12-14 Months of Age | PHASE2 | COMPLETED | 1,851 | — | — | Nov 20, 2007 | Mar 17, 2009 | Oct 9, 2018 | 141 | United States |
Confirmed varicella case = A case that met the clinical case definition \[an illness with acute onset of diffuse, generalized maculopapulovesicular rash (i.e. spots, papules and/or vesicles) without other apparent cause\] at least in the opinion of the investigator and was confirmed by laboratory test \[Polymerase Chain Reaction (PCR) (+)\] OR a case that met the clinical definition confirmed by the Independent Data Monitoring Committee (IDMC) and was epidemiologically linked \[Epi (+)\] to a valid index case.
Seroresponse for antibodies to VZV is defined as the appearance post-vaccination of anti-VZV antibodies \[concentration greater than or equal to the threshold of 75 milli-international units per milliliter (mIU/mL)\] in the serum of subjects below the assay cut-off value of 25 mIU/mL before vaccination.
Concentrations are given as Geometric Mean Concentrations (GMCs).
Seroresponse for antibodies to mumps virus is defined as the appearance post-vaccination of anti-mumps virus antibodies \[titer greater than or equal to the threshold of 51 Effective Doses (ED50)\] in the serum of subjects below the assay cut-off value of 24 ED50 before vaccination.
Seroresponse for antibodies to measles virus is defined as the appearance post-vaccination of anti-measles virus antibodies \[concentration greater than or equal to the threshold of 200 milli-international units per milliliter (mIU/mL)\] in the serum of subjects below the assay cut-off value of 150 mIU/mL before vaccination.
Seroresponse for antibodies to rubella virus is defined as the appearance post-vaccination of anti-rubella virus antibodies \[concentration greater than or equal to the threshold of 10 international units per milliliter (IU/mL)\] in the serum of subjects below the assay cut-off value of 4 IU/mL before vaccination.
Concentrations are given as Geometric Mean Concentrations (GMCs).
Concentrations are given as Geometric Mean Concentrations (GMCs).
| Arm | Type | Description |
|---|---|---|
| MMRV Group | EXPERIMENTAL | Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2). |
| OKAH Group | EXPERIMENTAL | Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm. |
| MMR Group | ACTIVE_COMPARATOR | Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2). |
| Group A | EXPERIMENTAL | Subjects received refrigerator-stored Priorix-Tetra™ (MMRV vaccine 208136 formulation A) co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180 |
| Group B | EXPERIMENTAL | Subjects received freezer-stored Priorix-Tetra™ (MMRV vaccine 208136 formulation B) co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180 |
| Group C | ACTIVE_COMPARATOR | Subjects received ProQuad® co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180 |
| Name | Type | Description |
|---|---|---|
| Priorix-tetra™ | BIOLOGICAL | 2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMRV Group |
| Priorix™ | BIOLOGICAL | 2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMR Group and one dose administered subcutaneously at Day 0 to subjects in OKAH Group |
| Varilrix™ | BIOLOGICAL | 1 dose administered subcutaneously at Day 42 to subjects in OKAH Group |
| Priorix-Tetra™ (MMRV vaccine 208136) | BIOLOGICAL | One subcutaneous injection. |
| ProQuad® | BIOLOGICAL | One subcutaneous injection. |
| Havrix® | BIOLOGICAL | Two intramuscular injections. |
| Prevnar® | BIOLOGICAL | One intramuscular injection. |
Inclusion criteria: * Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol for the whole duration of the study. * Male or female subject between 12 and 22 months of age at the time of the first vaccination. * Subjects fre...